BREAKING: MAPS PBC Files New Drug Application for MDMA-Assisted Therapy for PTSD

The natural question arising is: when might we expect to hear about a decision from the FDA?The answer—perhaps unsurprisingly—is that it’s complicatedIf the FDA decides that MAPS PBC’s NDA is complete, it generally aims to make a decision within 6 to 10 months.However, the fact that MDMA will be considered a new molecular entity in the eyes of the FDA will likely lengthen the process—usually tagging on a couple of months to the approval timeline.It’s also very likely that MDMA-AT will be subject to a Risk Evaluation and Mitigation Strategy (REMS; see our Library entry for more), which will take time to devise, negotiate and implement.On the other hand, MAPS PBC does have some tailwinds. Notably, MDMA-AT’s Breakthrough Therapy Designation, which aims to expedite the review process. Indeed, MAPS PBC will request that FDA grant Priority Review of the package.MAPS PBC also secured a Special Protocol Assessment in 2017, which represents some level of agreement between the company and the FDA with regards to study design. This should ensure that the Phase 3 data MAPS PBC includes in its NDA is acceptable to the FDA for the purposes of market approval. The FDA also agreed to rolling review of portions of MAPS PBC’s NDA in November 2021.These tailwinds and headwinds might cancel each other out to some extent, meaning that the upper end of FDA’s “6 to 10 months” timeline might be a reasonable expectation.As part of that deliberation, we should expect to see the FDA convene an Advisory Committee, perhaps during the summer.If the FDA approves MDMA-AT for PTSD, DEA rescheduling would then take place. This could take up to three months at the federal level, with more than twenty states also having to reschedule at the state level. (See our Library entry on bifurcated scheduling for more.)As such, we might hope to see MDMA-AT approved for PTSD in (late) 2024. If all goes to plan, we might even see the first patients receiving the therapy before the end of next year, though numbers would be small.



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